Overview

Continuing Education credits are not available for the archived offering. This archived webinar is available for purchase through April 30, 2015.Duration: 1 hour 21 minutes

Essential information and practical skills are needed to build a strong foundation for identifying and managing risks to quality in the protocol development process. Quality by Design (QbD) emphasizes building quality into the process from the beginning to help avoid risks from becoming realized. The Critical to Quality (CTQ) parameters also need to be identified. This webinar will outline what aspects of a trial have a meaningful impact on patient safety and interpretation of trial results, including:

What proactive steps can be taken to avoid risks/problems inherent in running a clinical study

Identification of critical to quality factors in protocol design

What ongoing checks can be performed to detect problems

How will the impact of any corrective actions be assessed

Who should attend?

Professionals involved in:

Clinical Development

Clinical Operations

Science

Academia

Medical Monitoring

Medical Writing

Regulatory Affairs

BioMetrics

Quality Assurance

Quality Management

Risk Management in support of Clinical and Device Trials

Learning objectives

At the conclusion of this webinar, participants should be able to:

Discuss the regulatory expectations for applying Protocol Quality by Design

Ways to register

Individual registration is a license for ONE internet login allowing one viewer.

Group site registration is a license for ONE internet login allowing multiple viewers from one location.

Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.

Cancellations: No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs

DIA is the global forum for knowledge exchange that fosters innovation to raise the level of health and well-being worldwide.

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